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NA 176

DIN Standards Committee Health Technologies

About NAGesuTech Projects Drafts Publications Documents withdrawn without replacement National committees European committees International committees

DIN EN ISO 15189 [CURRENT] references following documents:

Document number	Edition	Title
ISO/IEC Guide 99	2007-12	International vocabulary of metrology - Basic and general concepts and associated terms (VIM) More
ISO/IEC 17000	2020-05	Conformity assessment - Vocabulary and general principles More
ISO/IEC 17025	2017-11	General requirements for the competence of testing and calibration laboratories More
DIN EN ISO 15194	2009-10	In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009 More
DIN EN ISO 17034	2017-04	General requirements for the competence of reference material producers (ISO 17034:2016); German and English version EN ISO 17034:2016 More
DIN EN ISO 17511	2021-11	In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021 More
DIN EN ISO 19011	2018-10	Guidelines for auditing management systems (ISO 19011:2018); German and English version EN ISO 19011:2018 More
DIN EN ISO 20166-1	2019-04	Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018); German version EN ISO 20166-1:2018 More
DIN EN ISO 20166-2	2019-04	Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018); German version EN ISO 20166-2:2018 More
DIN EN ISO 20166-3	2019-04	Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018); German version EN ISO 20166-3:2019 More

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